ritonavir

Generic: ritonavir

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ritonavir
Generic Name ritonavir
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ritonavir 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-687
Product ID 65862-687_dca8eddf-c54f-4b6e-b56c-19d6dd3e7e90
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206614
Listing Expiration 2026-12-31
Marketing Start 2018-09-17

Pharmacologic Class

Established (EPC)
cytochrome p450 3a inhibitor [epc] protease inhibitor [epc]
Mechanism of Action
hiv protease inhibitors [moa] cytochrome p450 3a inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 2c19 inducers [moa] cytochrome p450 3a inducers [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 1a2 inducers [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 2b6 inducers [moa] udp glucuronosyltransferases inducers [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862687
Hyphenated Format 65862-687

Supplemental Identifiers

RxCUI
900575
UPC
0365862687302
UNII
O3J8G9O825
NUI
N0000000246 N0000191001 N0000175889 N0000190114 N0000182137 N0000185607 N0000190118 N0000185503 N0000190113 N0000182141 N0000191266 N0000185507 N0000187064 N0000190117

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ritonavir (source: ndc)
Generic Name ritonavir (source: ndc)
Application Number ANDA206614 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-687-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-687-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-687-30)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65862-687-99)
source: ndc

Packages (4)

65862-687-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-687-01) 65862-687-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-687-05) 65862-687-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-687-30) 65862-687-99 1000 TABLET, FILM COATED in 1 BOTTLE (65862-687-99)

Ingredients (1)

ritonavir (100 mg/1)

Linked Drug Pages (1)

Ritonavir ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dca8eddf-c54f-4b6e-b56c-19d6dd3e7e90", "openfda": {"nui": ["N0000000246", "N0000191001", "N0000175889", "N0000190114", "N0000182137", "N0000185607", "N0000190118", "N0000185503", "N0000190113", "N0000182141", "N0000191266", "N0000185507", "N0000187064", "N0000190117"], "upc": ["0365862687302"], "unii": ["O3J8G9O825"], "rxcui": ["900575"], "spl_set_id": ["11f757f1-cf48-47a8-925e-918359cbd2d4"], "pharm_class_epc": ["Cytochrome P450 3A Inhibitor [EPC]", "Protease Inhibitor [EPC]"], "pharm_class_moa": ["HIV Protease Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "UDP Glucuronosyltransferases Inducers [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-687-01)", "package_ndc": "65862-687-01", "marketing_start_date": "20180917"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-687-05)", "package_ndc": "65862-687-05", "marketing_start_date": "20180917"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-687-30)", "package_ndc": "65862-687-30", "marketing_start_date": "20180917"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65862-687-99)", "package_ndc": "65862-687-99", "marketing_start_date": "20180917"}], "brand_name": "Ritonavir", "product_id": "65862-687_dca8eddf-c54f-4b6e-b56c-19d6dd3e7e90", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 3A Inhibitor [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "HIV Protease Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Protease Inhibitor [EPC]", "UDP Glucuronosyltransferases Inducers [MoA]"], "product_ndc": "65862-687", "generic_name": "Ritonavir", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ritonavir", "active_ingredients": [{"name": "RITONAVIR", "strength": "100 mg/1"}], "application_number": "ANDA206614", "marketing_category": "ANDA", "marketing_start_date": "20180917", "listing_expiration_date": "20261231"}